"Indian pharmaceutical exports recorded 18% Growth from FY2019-20 to FY 2020-21, the highest growth rate ever recorded."

Lakshmi Prasanna Chundu

DIRECTOR - REGULATORY AFFAIRS, THE PHARMACEUTICAL EXPORT PROMOTION COUNCIL OF INDIA (PHARMEXCIL)

November 18, 2022

Can you speak of Pharmexcil’s role within India's life sciences sector?

The Pharmaceutical Export Promotion Council of India (Pharmexcil) is a council formed under the foreign trade policy to facilitate the exports of pharmaceuticals and allied products by way of assisting the Indian manufacturers in terms of international market exploration. We have approximately 3,700 members dealing with formulations, APIs, biologicals, vaccines, contract research and manufacturing, and analytical services.

Pharmexcil advocates for policy measures that support exportation, conducts market due diligence to identify areas of opportunity, and helps connect our members with international partners. With the support of the government, we host international events and exhibitions for networking opportunities and focused B2B meetings. We also assist our members with regulatory developments happening in international markets and have capacity-building programs and regulatory awareness workshops to educate them on international scenarios.

How have pandemic-related supply chain disruptions impacted India's volume of pharmaceutical exports?

Pharmexcil conducted a study on strategies to reduce import dependence on APIs and identified the major APIs and key raw materials that the Indian industry currently lacks. This has helped the Department of Pharmaceuticals develop the PLI scheme to strengthen domestic industry capabilities to meet domestic needs.

Pharmexcil also facilitates procurement/sourcing of medicines by the global community, and we played a pivotal role during the pandemic during which many countries needed critical medicines. With all our efforts coupled with industries' capabilities in meeting global demand, Indian pharmaceutical exports recorded 18% Growth from FY2019-20 to FY 2020-21, the highest growth rate ever recorded. Our exports jumped from US$20.7 billion in FY-2020 to US$24.4 billion in FY-2021.

What role does the MAI scheme play in promoting sustainable growth of India’s life sciences sector?

The MAI (Market Access Initiative) scheme encourages new entrepreneurs to embark on exports by taking them to BSMs giving them exposure to different markets with assistance in providing information and introducing them to the reputed importers.

MAI scheme also helps all companies to obtain market authorizations, GMP certifications etc. from different countries meeting their clientele specifics in terms of GMP and quality of the final product by providing financial assistance to meet 50% of the basic cost they have incurred for statutory compliances to a max of Rs.2.00 Cr per year. This would encourage the industry to get market authorisations for their range of products and is even applicable for patent filings, bio equivalence studies, and quality certification of natural products. This will increase the industry’s access to global markets. MAI also encourages the MSME units with 30Cr FOB for installation of bar-coding facilities with a max incentive of Rs25 Lakh to meet the Regulatory compliance of DGFT notification on Track & Trace obligation for exports.

What work can be done to improve India’s image as a reliable provider of high-quality pharmaceutical products?

Pharmexcil has recently conducted Global Regulators Conclave at IPHEX 2022 inviting over 75 officials from 50 overseas regulatory agencies on the theme “International Regulatory Convergence to Promote Accessibility and Affordability of Quality Medicines”. This interaction among the Global Regulators & procurement agencies with Indian Regulators has paved a way for enhanced collaborations among the agencies by way of MoUs & Mutual Reliance Mechanism.

It has provided opportunities for showcasing the high-quality Indian companies adhere to, while understanding the latest outlook of the visiting regulatory agencies’ requirements.

What are your projections for India's pharmaceutical market in the coming years?

For 2022, there is a target of US$27.4 billion for Indian pharma exports, which we are optimistic the industry will hit. The international generics market is projected to grow at a 6% CAGR for the next five years. The Indian generics export market has been recording almost 2.5 times growth compared to the global generics market, and in that sense, we could extrapolate the growth of the Indian pharma industry to 10% CAGR for the next five years, with exports then possibly reaching US$40 billion in the next five years.

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